Each year universities in the United States carry out more than $30-billion in medical research and involve tens of thousands of volunteers. And even though most of that research is paid for with federal money, the volunteers have no federal guarantee of care or compensation if anything goes wrong.
In fact, federal officials acknowledge, the government doesn’t even have a reliable method of finding out how many volunteers for tests of new drugs and medical devices have been harmed.
But that may be about to change.
A presidential commission, after more than a year of study, is set to outline recommendations this week that would strengthen protections for the estimated 50,000 people who take part each year in federally sponsored medical research. One key recommendation could establish new requirements for universities to treat and compensate anyone who is harmed, intentionally or otherwise. Some universities already offer such benefits, though the extent of the practice is unclear.
“There’s an ethical case for compensation,” the chair of the Presidential Commission for the Study of Bioethical Issues, Amy Gutmann, told the panel last month. Ms. Gutmann is also president of the University of Pennsylvania.
The commission began studying the problem in November 2010 after a researcher at Wellesley College, Susan M. Reverby, found that in the 1940s U.S. scientists intentionally infected hundreds of people in Guatemala with gonorrhea and syphilis as part of a public-health research project.
Obama Seeks Guidance
President Obama responded by asking the bioethics commission to investigate and to advise him on whether existing federal guidelines were sufficient for protecting human beings during medical tests.
The commission completed the first part of that assignment in September, issuing a report that laid blame for the Guatemala experiments on a series of top public-health officials at the time. “The Guatemala experiments involved unconscionable violations of ethics, even as judged against the researchers’ own understanding of the practices and requirements of medical ethics of the day,” the commission wrote.
But the commission has been less definitive about converting its findings about those long-ago experiments into policy recommendations. Commission members said they recognized that current U.S. government and university leaders weren’t likely to infect unsuspecting patients intentionally. Less easy to answer, however, are questions like whether U.S. researchers should go overseas in search of cheaper and less complicated study environments, and whether researchers should have plans for compensating the subjects if an experiment goes awry.
The president’s commission has 13 members, nine with current university affiliations. Along with their review of the Guatemala experiments, the members studied more-recent cases, such as federally financed tests in Africa during the 1990s of methods for preventing mother-to-child transmission of AIDS. Many women in the trial were given a placebo, even though the drug AZT was known to be effective in saving the lives of children.
The commission also heard from industry representatives who acknowledged that they conduct some drug trials overseas to save money. They denied, however, that they operated with less regulation or weaker ethical safeguards in foreign locales.
Useful comparisons between American and international standards are elusive, commission members said. That’s partly because the U.S. government requires federally financed researchers operating overseas to follow U.S. standards for human-subjects protection. But the United States has repeatedly cast aside requests from other countries to synchronize policies for protecting study participants.
“To date,” one commission member, Lonnie Ali, told the panel last month, “the Office of Human Research Protections has not formally recognized any country’s protections as equivalent.”
Lack of Data
Again and again, the commission found itself troubled by the lack of hard data. Ms. Gutmann said that the leading provider of federal money for medical research, the National Institutes of Health, has a good system for making its grants database available online. But 18 federal departments and agencies are involved in human-subjects research, and commission members said many of them could not supply basic facts, such as the number of research subjects enrolled in their projects and whether they have encountered any problems. One likely commission recommendation is that those agencies create common sets of computerized data that could be tallied governmentwide.
As a general rule, private companies involved in experiments with human subjects already offer coverage for injuries caused by investigational drugs, said Jeffrey K. Francer, assistant general counsel of the Pharmaceutical Research and Manufacturers of America.
Many universities do the same. One of the biggest participants in federally sponsored medical research is the University of Washington, which provides free medical care and up to $10,000 for out-of-pocket expenses to anyone harmed by a research trial, regardless of fault.
The university’s assistant vice provost for research, Karen E. Moe, said she recognized that smaller institutions, especially those without their own hospital systems, might not be able to afford such generosity. But, she told the commission, relatively few people actually take advantage of it.
The program has cost the University of Washington a little over $250,000 over the past five years, Ms. Moe said. Examples of claims include a patient who chewed on a vitamin wafer and fractured an old filling and crown on a tooth. The woman “saw her own dentist and we covered her dental bill for $245,” she said.
The presidential commission is wrapping up its report for Mr. Obama just as the Office for Human Research Protections is beginning a thorough overhaul of all rules governing human experimentation. Many universities have looked forward to the overhaul as a chance to simplify some rules and ease some of the associated burdens. But now the presidential commission, with its talk of new data-sharing and mandatory-compensation systems, could be setting the stage for even greater regulatory burdens.
Ms. Gutmann and other commission members took pains to suggest otherwise. On the question of mandating care and compensation to research-study subjects who need it, the commission is likely to suggest the government examine whether there are in fact large numbers of study participants with unmet medical needs.
“There is an ethical case for compensation,” Ms. Gutmann reiterated to the panel. “The question is whether there is a need for something new to be done.”